Our client located in Wilmington, MA is looking for a Qualty Engineer to join their team on a direct hire basis.
The Quality Engineer will provide Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).
- Technical support for and final review and approval of customer complaint investigations
- Support new product development
- Facilitate the execution of Risk Management activities
- Identify statistically based sampling plans for inspections and validations
- Support validations for new and existing products, processes and equipment
- Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
- Participate in FDA inspections, ISO Registration and surveillance audits and customer audits
- Identify and implement opportunities for continuous improvement
- Interact and coordinate activities with other departments, external vendors and customers
- Assist or lead in the identification and implementation of CAPA
- Aid in the implementation SPC control system with Manufacturing and Quality Control
- Supports internal quality system audits
- Provides support necessary for supplier controls, including but not limited to: supplier audits
- Participates in Post-Market Surveillance (PMS) activities as required
- Collection and reporting of metrics and data as required
- Performs other Quality System related duties as required
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
Education: BS degree in Engineering, Science (Biology, Chemistry, Physics, etc.), or Math (Statistics)
Certification: Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus
- Minimum of two years of Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment
- Knowledge of statistical sampling and analysis
- Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards
- Ability to read blueprints and interpret Geometric Dimensioning and Tolerancing (GD&T)
- Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean Manufacturing, etc.).
- Knowledge of various MS Office applications such as: Word, Excel, and Powerpoint, including Microsoft Visio and Project
- Excellent organizational, written, and verbal communication skills
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner
- Strong problem solving, leadership, and analytical skills
- Outstanding attention to detail
- Must be able to observe company policies and safety procedures at all times
- Must be able to treat others with respect; work with integrity and ethically; uphold organizational values